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Vaccine and Treatment Evaluation Units (VTEUs)

Clinical Trials of 2009 H1N1 Flu Vaccines in NIAID’s VTEUs

NIAID has initiated trials of experimental vaccines to prevent and decrease the severity of novel H1N1 flu virus infection. The trials involve thousands of volunteers recruited by eight NIAID-supported VTEUs and other medical centers nationwide.

Initial studies are examining whether one or two 15 microgram doses of H1N1 vaccine are needed to induce a potentially protective immune response in healthy adult volunteers, including elderly people. Researchers are also assessing whether one or two 30 microgram doses are needed. The doses will be given 21 days apart, testing two manufacturers’ vaccines (Sanofi Pasteur and CSL Biotherapies). NIAID is also conducting studies to determine the safety of the vaccines in special populations, including healthy children and pregnant women, and trials that test the H1N1 vaccine with an adjuvant—a substance that can boost the effectiveness of the vaccine.

Another question these trials are seeking to answer is whether seasonal flu vaccine can be given concurrent with—either before, after or during—the H1N1 vaccine.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.

The H1N1 Flu Candidate Vaccines

Manufacturers have supplied vaccines to the VTEUs for evaluation in volunteers. Sanofi-Pasteur and CSL Biologics supplied the first two vaccines for testing. The initial trials are testing vaccines only containing antigen—the part of the virus that elicits a host immune response. NIAID is also conducting trials to test vaccines combining antigen with an adjuvant—a substance that can boost the effectiveness of the vaccine, so less antigen is needed. The adjuvant is made by GlaxoSmithKline (GSK).